Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00469560
Eligibility Criteria:
Inclusion Criteria:
* Patients, both males and females, with low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.
* Age \>=18 years
* Patients who never received chelation therapy or who received a therapy with Desferal after a day of wash out
* Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate).
* Availability of data concerning blood transfusions during the 12 weeks before screening
* Serum ferritin \>= 1000 µg/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening
* Life expectancy \> 12 months
* Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening
Exclusion Criteria:
* Diagnosis different from MDS (i.e. myelofibrosis)
* Severe renal impairment (creatinine clearance \< 60 ml/min)
* ALT/AST \> 500 U/L
* Active B and/or C hepatitis
* Patients treated during the past 4 weeks with experimental drugs for MDS (including thalidomide, azacitidine, arsenic trioxide). These patients become eligible after a "wash out" of at least 4 weeks
* Concomitant treatment with another iron-chelating agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00469560
Study Brief:
Protocol Section:
NCT00469560